Postmenopausal Osteoporosis
Conditions
Brief summary
The purpose of this study is to determine which of two delivery methods of Parathyroid Hormone (PTH) is preferred by patients after 14 days of use for each.
Detailed description
The purpose of this study is to determine which of two delivery methods of PTH is preferred by patients after 14 days of use for each. Patient preference will be determined by means of patient questionnaires at the end of each treatment period and a final questionnaire after both treatment periods are complete. Adverse events will also be collected.
Interventions
DRUGZP-PTH
Patch applied daily for 30 minutes, 14 days
DRUGFORTEO
Subcutaneous injection administration daily for 14 days
Sponsors
Zosano Pharma Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
55 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Postmenopausal with prior diagnosis of osteoporosis
Exclusion criteria
* Significant health issue * previous use of teriparatide * History of Paget's disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Preference | 28 days | The fraction of subjects expressing an overall preference for each treatment based on a 4 point scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety (adverse events) | 28 days | incidence of adverse events |
Countries
United States
Outcome results
None listed